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Effect of Orthokeratology Versus Spectacles on Myopia Progression in Chinese Children: A Crossover Trial

NCT ID: NCT02186184

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-10-31

Brief Summary

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Orthokeratology is becoming popular for the treatment of myopia children. Many studies have shown that orthokeratology is effective in temporarily reducing refractive error, and is also helpful for controlling myopia progression. However, the mechanism for its slowing myopia progression and rebound effect after the treatment have not been clearly studied. In addition, the effect of orthokeratology among Chinese children has not been evaluated with randomized controlled trial.This study is to assess the effect of orthokeratology versus spectacles on myopia progression in school-aged Chinese children during two years.

Detailed Description

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Conditions

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Myopia

Keywords

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Myopia progression Orthokeratology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Orthokeratology in the first year

The participants would wear orthokeratology in the first year and then switch to spectacle in the second year

Group Type EXPERIMENTAL

Orthokeratology

Intervention Type DEVICE

Spectacle

Intervention Type DEVICE

Spectacle in the first year

The participants would wear spectacle in the first year and then changed to orthokeratology in the second year

Group Type ACTIVE_COMPARATOR

Orthokeratology

Intervention Type DEVICE

Spectacle

Intervention Type DEVICE

Interventions

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Orthokeratology

Intervention Type DEVICE

Spectacle

Intervention Type DEVICE

Other Intervention Names

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Glasses

Eligibility Criteria

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Inclusion Criteria

* Ages Eligible for Study: 7 Years to 14 Years
* Genders Eligible for Study: Both
* Visual acuity 20/20 or better in each eye
* Spherical error ranging from -0.5 D to -5.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes
* No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development

Exclusion Criteria

* Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on)
* Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing
Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shi-Ming Li

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ningli Wang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University

Locations

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Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2014CB504601

Identifier Type: -

Identifier Source: org_study_id